PTSDNCT01211106
Integrated vs Sequential Treatment for PTSD and Addiction
A study testing Prolonged Exposure and Motivational Enhancement Therapy in people with PTSD and Substance Addiction, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The investigators are examining different treatment strategies of helping patients with PTSD and addiction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD, Substance Addiction
- What is being tested?
- Prolonged Exposure and Motivational Enhancement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Persian Gulf Era veterans between 18-65 years old. Older individuals are unlikely to have served in Iraq or Afghanistan.
- Current diagnosis of PTSD (symptom duration > 3 months) with clinically significant trauma-related symptoms, as indicated by a score of at least 50 on the PCL
- Current abuse or dependence on alcohol, stimulants such as cocaine, opioids, including prescription opioids or benzodiazepines. Subjects must report using on average at least 10 out of 30 days prior to signing consent. Of note: subjects can be abusing or dependent upon nicotine or marijuana but these will not be considered sufficient for inclusion
- Provides informed consent
- Speaks and reads English
Who cannot join
- Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment
- Meets current DSM-IV criteria for bipolar affective disorder, schizophrenia or any psychotic disorder
- Has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease
- History of moderate or severe traumatic brain injury (TBI)
- Participation in Prolonged Exposure Therapy in the last 6 months.
- Initiation of a new psychotherapy program in the last 2 months.
Show all 9Show fewer
- Active participation in a formal addiction treatment program. Actively engaged is defined as any visit in the program in the prior month and pending future appointments for the treatment of addictions
- Change in psychotropic medication in the 1 month prior to treatment except for the use of oxazepam for alcohol detoxification or a taper of a previously used benzodiazepine.
- Therapeutic use of a benzodiazepine greater than the equivalent of more than 40 mg of diazepam (see chart) at the time of randomization.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
About this study
Official title: Integrated vs Sequential Treatment for PTSD and Addiction Among OEF/OIF Veterans
The investigators are examining different treatment strategies of helping patients with PTSD and addiction.
Read the detailed description
The investigators hypothesize that Veterans in the integrated conditions will show greater reductions in substance abuse and PTSD symptom severity at the end of treatment and at 6 and 9 month follow-ups. The investigators further hypothesize that offering Veterans Prolonged Exposure (PE) at the onset of treatment in the integrated condition will leader to greater retention and satisfaction than in the sequential treatment design.
- Conditions
- PTSD, Substance Addiction
- Being tested
- Prolonged Exposure, Motivational Enhancement Therapy
- Keywords
- Treatment, PTSD, Addiction
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged ExposureBehavioural
Although almost every form of psychotherapy has been advocated for PTSD, all evidence-based psychotherapies for PTSD are CBT programs that include variants of exposure therapy (Prolonged Exposure), cognitive therapy (CT), stress inoculation training (SIT), eye movement desensitization and reprocessing (EMDR), or combinations of these procedures. Exposure therapy involves helping PTSD sufferers to gradually confront distressing trauma-related memories and reminders to facilitate successful emotional processing of the trauma memory and reduction of associated distress. Most exposure therapy programs include both imaginable confrontation with the traumatic memories and in vivo exposure to trauma reminders.
Motivational Enhancement TherapyBehavioural
Motivational Interviewing (MI) is defined as a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI is characterized by its spirit, which is defined as collaboration with the client, evocation of the client's own perceptions, goals, and values, and respect for the client's autonomy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Integrated Conditions | Experimental | Motivational enhancement therapy for addiction is combined with Prolonged exposure therapy for PTSD from the beginning of treatment. Both are delivered by the same provider throughout treatment. Receives: Behavioral: Prolonged Exposure; Behavioral: Motivational Enhancement Therapy |
| Arm 2 Sequential therapy | Experimental | Motivational enhancement therapy for addiction is delivered in the first 4 weeks and only after the addiction is addressed is the Prolonged exposure therapy for PTSD started. Receives: Behavioral: Prolonged Exposure; Behavioral: Motivational Enhancement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptoms
PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms.
Measured: 16 weeks
Drinking Outcome
Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startFeb 2011
- Primary completionMar 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David W. Oslin, MD, Principal investigator, Philadelphia VA Medical Center, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211106
- Sponsor's protocol ID
- ZDA1-03-W10
- Status last verified
- Jan 2017
- First submitted
- 27 Sep 2010
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Alpert E, Kaplan A, Nelson D, Oslin DW, Polusny MA, Ingram EP, Kehle-Forbes SM. Clusters Based on Within-Treatment Symptom Trajectories as Predictors of Dropout in Treatment for Posttraumatic Stress Disorder and Substance Use Disorder. J Dual Diagn. 2024 Jun 6:1-21. doi: 10.1080/15504263.2024.2355953. Online ahead of print.
PubMed 38843038Scott JC, Lynch KG, Cenkner DP, Kehle-Forbes SM, Polusny MA, Gur RC, Chen S, Foa EB, Oslin DW. Neurocognitive predictors of treatment outcomes in psychotherapy for comorbid PTSD and substance use disorders. J Consult Clin Psychol. 2021 Nov;89(11):937-946. doi: 10.1037/ccp0000693.
PubMed 34881912Kehle-Forbes SM, Drapkin ML, Foa EB, Koffel E, Lynch KG, Polusny MA, Van Horn DH, Yusko DA, Charlesworth M, Blasco M, Oslin DW. Study design, interventions, and baseline characteristics for the Substance use and TRauma Intervention for VEterans (STRIVE) trial. Contemp Clin Trials. 2016 Sep;50:45-53. doi: 10.1016/j.cct.2016.07.017. Epub 2016 Jul 19.
PubMed 27444425
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated vs Sequential Treatment for PTSD and Addiction Among OEF/OIF Veterans
- ClinicalTrials.gov ID
- NCT01211106
- Acronym / sponsor ID
- ZDA1-03-W10
- Conditions
- PTSD, Substance Addiction
- Keywords
- Treatment, PTSD, Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Feb 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Sep 2010 (estimated)
- Results
- Posted 9 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are examining different treatment strategies of helping patients with PTSD and addiction.
Detailed description
The investigators hypothesize that Veterans in the integrated conditions will show greater reductions in substance abuse and PTSD symptom severity at the end of treatment and at 6 and 9 month follow-ups. The investigators further hypothesize that offering Veterans Prolonged Exposure (PE) at the onset of treatment in the integrated condition will leader to greater retention and satisfaction than in the sequential treatment design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Integrated Conditions | Experimental | Behavioral: Prolonged Exposure, Behavioral: Motivational Enhancement TherapyMotivational enhancement therapy for addiction is combined with Prolonged exposure therapy for PTSD from the beginning of treatment. Both are delivered by the same provider throughout treatment. |
| Arm 2 Sequential therapy | Experimental | Behavioral: Prolonged Exposure, Behavioral: Motivational Enhancement TherapyMotivational enhancement therapy for addiction is delivered in the first 4 weeks and only after the addiction is addressed is the Prolonged exposure therapy for PTSD started. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female Persian Gulf Era veterans between 18-65 years old. Older individuals are unlikely to have served in Iraq or Afghanistan.
- Current diagnosis of PTSD (symptom duration > 3 months) with clinically significant trauma-related symptoms, as indicated by a score of at least 50 on the PCL
- Current abuse or dependence on alcohol, stimulants such as cocaine, opioids, including prescription opioids or benzodiazepines. Subjects must report using on average at least 10 out of 30 days prior to signing consent. Of note: subjects can be abusing or dependent upon nicotine or marijuana but these will not be considered sufficient for inclusion
- Provides informed consent
- Speaks and reads English
Key exclusion criteria (9 listed)
- Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment
- Meets current DSM-IV criteria for bipolar affective disorder, schizophrenia or any psychotic disorder
- Has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease
- History of moderate or severe traumatic brain injury (TBI)
- Participation in Prolonged Exposure Therapy in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged ExposureAlthough almost every form of psychotherapy has been advocated for PTSD, all evidence-based psychotherapies for PTSD are CBT programs that include variants of exposure therapy (Prolonged Exposure), cognitive therapy (CT), stress inoculation training (SIT), eye movement desensitization and reprocessing (EMDR), or combinations of these procedures. Exposure therapy involves helping PTSD sufferers to gradually confront distressing trauma-related memories and reminders to facilitate successful emotional processing of the trauma memory and reduction of associated distress. Most exposure therapy programs include both imaginable confrontation with the traumatic memories and in vivo exposure to trauma reminders. | Behavioural | Arm 1: Integrated Conditions, Arm 2 Sequential therapy |
| Motivational Enhancement TherapyMotivational Interviewing (MI) is defined as a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI is characterized by its spirit, which is defined as collaboration with the client, evocation of the client's own perceptions, goals, and values, and respect for the client's autonomy. | Behavioural | Arm 1: Integrated Conditions, Arm 2 Sequential therapy |
Primary outcome
PTSD Symptoms
Time frame: 16 weeks
PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms.
Drinking Outcome
Time frame: 16 weeks
Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38843038Alpert E, Kaplan A, Nelson D, Oslin DW, Polusny MA, Ingram EP, Kehle-Forbes SM. Clusters Based on Within-Treatment Symptom Trajectories as Predictors of Dropout in Treatment for Posttraumatic Stress Disorder and Substance Use Disorder. J Dual Diagn. 2024 Jun 6:1-21. doi: 10.1080/15504263.2024.2355953. Online ahead of print.
- Derived from this study: PubMed 34881912Scott JC, Lynch KG, Cenkner DP, Kehle-Forbes SM, Polusny MA, Gur RC, Chen S, Foa EB, Oslin DW. Neurocognitive predictors of treatment outcomes in psychotherapy for comorbid PTSD and substance use disorders. J Consult Clin Psychol. 2021 Nov;89(11):937-946. doi: 10.1037/ccp0000693.
- Derived from this study: PubMed 27444425Kehle-Forbes SM, Drapkin ML, Foa EB, Koffel E, Lynch KG, Polusny MA, Van Horn DH, Yusko DA, Charlesworth M, Blasco M, Oslin DW. Study design, interventions, and baseline characteristics for the Substance use and TRauma Intervention for VEterans (STRIVE) trial. Contemp Clin Trials. 2016 Sep;50:45-53. doi: 10.1016/j.cct.2016.07.017. Epub 2016 Jul 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W. Oslin, MD principal investigator
Philadelphia VA Medical Center, Philadelphia, PA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure and Motivational Enhancement Therapy in people with PTSD and Substance Addiction, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptoms (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01211106, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.